NCT00549484

Brief Summary

Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
Last Updated

January 18, 2008

Status Verified

January 1, 2008

Enrollment Period

1.3 years

First QC Date

October 24, 2007

Last Update Submit

January 16, 2008

Conditions

Thrombocytopenia

Keywords

ThrombocytopeniaThrombopoietinPlatelet TransfusionPlatelet Factor 4

Outcome Measures

Primary Outcomes (1)

  • Reduction in TPO levels following platelet transfusion

    Within 36 hours of transfusion

Secondary Outcomes (1)

  • Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.

    Within 36 hours after platelet transfusion

Study Arms (2)

1

10 mL/kg platelet transfusion

2

15 mL / kg platelet transfusion

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Infants who require platelet transfusion

You may qualify if:

  • Preterm infants with thrombocytopenia
  • Decision made by medical team to transfuse with platelets

You may not qualify if:

  • Infants with major congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were collected pre and post platelet transfusion. Samples included platelet count, thrombopoietin, and platelet factor 4.

MeSH Terms

Conditions

ThrombocytopeniaJacobs syndrome

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Alex Kline, MD

    Christiana Hospital

    PRINCIPAL INVESTIGATOR

  • David A. Paul, MD

    Christiana Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

May 1, 2003

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

January 18, 2008

Record last verified: 2008-01

Locations

US(1)